USP Backs Down From Biologic Monograph Naming Plan Amid US FDA Objections
Executive Summary
Proposed change was aimed at protecting monograph-covered products subject to March 2020 'transition provisions,’ but agency’s objections went to the heart of the monograph system; other stakeholder groups said proposed change would amount to an endorsement of FDA's flawed and unjustified suffix-based naming system for biologics.
You may also be interested in...
US FDA Vs. USP: Regulator Sees Biologic Product Monographs As Barrier To Biosimilars
USP's proposed change aimed at harmonizing with FDA's suffix-based naming system for biologics would 'aggravate existing concerns' that biologic product-specific monographs are too inflexible and may impede development of biosimilars, agency says in a letter publicized through a tweet by the commissioner.
FDA Biologic Transition Plan Creates 'Dead Zone' For Applications, Sponsors Fear
Industry objects to proposal that certain protein product applications pending as of March 23, 2020, will have to be resubmitted as BLAs – and to the idea that transitioned products will lose non-orphan exclusivity.
BLAs More Appealing As 'Transition' NDAs, ANDAs Set To Lose Exclusivity
Certain protein products approved under FD&C Act before March 23, 2020 would lose their remaining non- orphan exclusivity, and would not qualify for 12-year biologic exclusivity.